AddictionPhase 2NCT03347643
The Effectiveness of tDCS on Internet Game Addiction
A Phase 2 study testing tDCS with real stimulation in people with Addiction and Internet Gaming Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators aimed to investigate the effect of transcranial direct current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status of Internet game addiction includes severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Addiction, Internet Gaming Disorder
- What is being tested?
- tDCS with real stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Sep 2017to 8 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Internet gaming disorder based on diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5.
Who cannot join
- History of seizure
- History of significant head injury
- Mental retardation
- Schizophrenia
- History of stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blind Clinical Trial to Evaluate the Effectiveness of Transcranial Direct Current Stimulation (tDCS) on Internet Game Addiction
In this study, the investigators aimed to investigate the effect of transcranial direct current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status of Internet game addiction includes severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity. The investigators hypothesized that real stimulation with tDCS on the dorsolateral prefrontal cortex will have higher effectiveness on severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity rather than sham stimulation with tDCS.
- Conditions
- Addiction, Internet Gaming Disorder
- Being tested
- tDCS with real stimulation, tDCS with sham stimulation
- Keywords
- Internet game addiction, Internet gaming disorder, transcranial direct current stimulation, response inhibition, craving, cue reactivity
- Medical subject headings
- Behavior, Addictive, Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS with real stimulationDevice
tDCS is a non-invasive brain stimulation. Real stimulation includes 2mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
tDCS with sham stimulationDevice
Sham stimulation includes 0mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| tDCS with real stimulation | Active comparator | A total of 25 patients will be allocated into active comparator with real stimulation with tDCS. Receives: Device: tDCS with real stimulation |
| tDCS with sham stimulation | Sham comparator | A total of 25 patients will be allocated into sham comparator with sham stimulation with tDCS. Receives: Device: tDCS with sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Measured: baseline
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Measured: 1 week
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Measured: 5 week
Young Internet Addiction Test (Y-IAT)
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Measured: 25 week
Secondary outcomes (5)
Direction error and successful stop ratio in the Stop signal task
The stop signal task is a neurocognitive task for assessing response inhibition.
Measured: baseline, 5 weeks, 25 weeks
Barratt impulsiveness scale-11
Barratt impulsiveness scale-11 is a self-report questionnaire consisting of 30 items. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). This scale scores three subscales: attentional impulsiveness, motor impulsiveness, and nonplanning impulsiveness. The total score ranges from 30 to 120 and higher scores indicate greater impulsivity.
Measured: baseline, 5 weeks, 25 weeks
Anti-saccade error rate in the attentional bias task
The attentional bias task is measured by anti-saccade task using eye-tracking analysis for assessing attentional bias on Internet gaming stimuli.
Measured: baseline, 5 weeks, 25 weeks
Late positive potential in the cue reactivity event-related potential
Event-related potential measures with cue reactivity task
Measured: baseline, 5 weeks, 25 weeks
Visual analogue scale
Subjective craving for Internet gaming ranging from 0 to 10. Higher score represents higher craving for gaming.
Measured: baseline, 1 week, 5 weeks, 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start22 Sep 2017
- Primary completion1 Sep 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with internet gaming disorder will be randomly allocated into 1) actual real stimulation with tDCS group, and 2) sham stimulation with tDCS group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Seok Choi, Seoul National University Hospital
- Investigators
- Jung-Seok Choi, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347643
- Sponsor's protocol ID
- 30-2017-10
- Status last verified
- Mar 2020
- First submitted
- 13 Nov 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JY, Jang JH, Choi AR, Chung SJ, Kim B, Park M, Oh S, Jung MH, Choi JS. Neuromodulatory Effect of Transcranial Direct Current Stimulation on Resting-State EEG Activity in Internet Gaming Disorder: A Randomized, Double-Blind, Sham-Controlled Parallel Group Trial. Cereb Cortex Commun. 2021 Jan 4;2(1):tgaa095. doi: 10.1093/texcom/tgaa095. eCollection 2021.
PubMed 34296150
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Clinical Trial to Evaluate the Effectiveness of Transcranial Direct Current Stimulation (tDCS) on Internet Game Addiction
- ClinicalTrials.gov ID
- NCT03347643
- Acronym / sponsor ID
- 30-2017-10
- Conditions
- Addiction, Internet Gaming Disorder
- Keywords
- Internet game addiction, Internet gaming disorder, transcranial direct current stimulation, response inhibition, craving, cue reactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, SMG-SNU Boramae Medical Center
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators aimed to investigate the effect of transcranial direct current stimulation (tDCS) on clinical status of Internet game addiction. The clinical status of Internet game addiction includes severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity. The investigators hypothesized that real stimulation with tDCS on the dorsolateral prefrontal cortex will have higher effectiveness on severity of addiction symptom, subjective craving for gaming, response inhibition and cue reactivity rather than sham stimulation with tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients with internet gaming disorder will be randomly allocated into 1) actual real stimulation with tDCS group, and 2) sham stimulation with tDCS group.
| Arm | Type | Receives |
|---|---|---|
| tDCS with real stimulation | Active comparator | Device: tDCS with real stimulationA total of 25 patients will be allocated into active comparator with real stimulation with tDCS. |
| tDCS with sham stimulation | Sham comparator | Device: tDCS with sham stimulationA total of 25 patients will be allocated into sham comparator with sham stimulation with tDCS. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of Internet gaming disorder based on diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5.
Key exclusion criteria (5 listed)
- History of seizure
- History of significant head injury
- Mental retardation
- Schizophrenia
- History of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS with real stimulationtDCS is a non-invasive brain stimulation. Real stimulation includes 2mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied. | Device | tDCS with real stimulation |
| tDCS with sham stimulationSham stimulation includes 0mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied. | Device | tDCS with sham stimulation |
Primary outcome
Young Internet Addiction Test (Y-IAT)
Time frame: baseline
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Young Internet Addiction Test (Y-IAT)
Time frame: 1 week
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Young Internet Addiction Test (Y-IAT)
Time frame: 5 week
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
Young Internet Addiction Test (Y-IAT)
Time frame: 25 week
The Y-IAT is rated on a five-point scale. Total scores for all 20 items range from 20 to 100.
5 secondary outcomes
Direction error and successful stop ratio in the Stop signal task
Time frame: baseline, 5 weeks, 25 weeks
Barratt impulsiveness scale-11
Time frame: baseline, 5 weeks, 25 weeks
Anti-saccade error rate in the attentional bias task
Time frame: baseline, 5 weeks, 25 weeks
Late positive potential in the cue reactivity event-related potential
Time frame: baseline, 5 weeks, 25 weeks
Visual analogue scale
Time frame: baseline, 1 week, 5 weeks, 25 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 34296150Lee JY, Jang JH, Choi AR, Chung SJ, Kim B, Park M, Oh S, Jung MH, Choi JS. Neuromodulatory Effect of Transcranial Direct Current Stimulation on Resting-State EEG Activity in Internet Gaming Disorder: A Randomized, Double-Blind, Sham-Controlled Parallel Group Trial. Cereb Cortex Commun. 2021 Jan 4;2(1):tgaa095. doi: 10.1093/texcom/tgaa095. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Seok Choi, MD, PhD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tDCS with real stimulation in people with Addiction and Internet Gaming Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young Internet Addiction Test (Y-IAT) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.